Senior Engineering Program Manager - Quality Core Team Member

Location: Dexter

We anticipate the application window for this opening will close on - 26 Jun 2026

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Cardio Vascular Surgery represents end stage treatment in the care continuum for many cardiovascular diseases and this OU provides an intimate relationship with the Cardiac Surgeon and Cardiac Operating Room by offering an unparalleled depth and breadth of portfolio.

Key Technologies:

* Surgical heart valves

* Cardiac OR solutions (e.g., blood management, cannulae)

* Extracorporeal life support

* Coronary artery bypass grafting (CABG) solutions

* Advanced endovascular therapies across the entire aorta

The Senior Engineering Program Manager role is for a Quality Core Team Member directly supporting new product development in Cardio Vascular Surgery. The role is responsible for managing the extended quality team as well as acting as the lead Design Assurance Engineer for the respective new product development program(s). Elaborated responsibilities can be found below.

Quality Core Team Member Responsibilities

* Support quality and reliability efforts for Cardio Vascular Surgery products, ensuring compliance with regulatory standards such as FDA CFR, MDR, and ISO 13485.

* Serve as the Quality Core Team Member; coordinate quality team members and ensure accountability for completing functional work within program deadlines from design concept to design transfer to early commercialization.

* Develop Quality functional strategies, plans, and schedules to meet project goals and manage risks.

* Represent Voice of Quality across all global Quality disciplines. Ensure quality requests are defined, implemented, and met (requests flow down) across the project.

* Collaborate with cross-functional teams, including R&D, regulatory affairs, and clinical teams, to ensure alignment on quality and compliance requirements.

* Maintain alignment and manage execution across global Quality disciplines. Communicate key program information to ensure Core Team and Quality leadership engagement and alignment.

* Plan and manage program resource allocation and budget.

* Identify quality program risks and implement risk burn down strategies.

* Ensure an effective transfer to global Post-Market Quality functions.

Design Assurance Engineering Responsibilities

* Review and approve Design History File and other related documentation, including plans, requirements, design, development, test protocols, test reports, verification, and validation. Ensure all documentation meets reliability standards and follows QMS processes.

* Develop and review documentation for traceability, testability, and compliance according to standard operating procedures.

* Develop expertise in assigned products and projects, including hands-on time in the engineering lab and participation in product training as assigned.

* Collaborates with R&D, systems engineering, and cross-functional teams to develop, qualify, and implement robust, repeatable, and compliant test method validations that ensure traceability and reliability of results.

* Proactively drive and champion strategic quality, reliability, and safety improvements through execution of the risk management process and DRM initiatives.

* Facilitate the development of the product risk management file. Ensure process is compliant to risk management procedures.

* Support hardware and software quality and reliability efforts for Cardio Vascular Surgery products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485.

Organizational Responsibilities

* Enhance product development and program management processes to improve compliance.

* Act as an independent quality reviewer for Cardio Vascular Surgery product development programs, guiding respective program teams to robust and compliant quality strategies, documentation, and decisions.

* Provides guidance, coaching, and training to other employees within Cardio Vascular Surgery.

Must Have:

Minimum Requirements
- To be considered for this role, please ensure the minimum requirements are evident in your applicant profile:

* Bachelor's degree

* Minimum of 7 years of relevant experience in quality or engineering

* Or an Advanced degree with a minimum of 5 years of relevant experience in quality or engineering.

Nice to Have

* Medical device industry experience

* A minimum of 2 years of program management experience.

* Experience in two or more of the following functions:
Design Assurance Engineering, Reliability Engineering, Post-Market Quality Engineering, Quality Systems, Operations Quality Engineering, Supplier Quality Engineering.

* Working knowledge of multiple quality disciplines, especially reliability, safety, and compliance.

* Master's degree in engineering or business administration.

* PMP certified.

* Proficient in leading…